Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

March 27, 2021 updated by: Jose Urbano Garcia, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Prospective, Multicenter, Non Randomized, Single Arm Study to Evaluate Safety of Transarterial Chemoembolization (TACE) With Doxorubicin Eluting 100 µ Microspheres in Patients With Non Resectable Hepatocellular Carcinoma

This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).

The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained.

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Target population includes:

  • Patients with stage B HCC carcinoma according to Barcelona Clinic Liver Cancer classification (BCLC).
  • Patients with stage A HCC according to BCLC if they are not candidates or not willing to go through surgery or radiofrecuency.

Description

Inclusion Criteria:

  1. Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria
  2. Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
  3. Able and willing to participate and give their written informed consent.
  4. Both genders and ≥ 18 years old.
  5. Eastern Cooperative Oncology Group (ECOG) 0
  6. Preserved hepatic function (Child-Pugh ≤ B7).
  7. No evidence of tumoral invasion in portal vein or main biliary ducts.
  8. Able to go through image diagnostic techniques such as CT or MRI.
  9. Preserved cardiac and renal function.
  10. No concomitant active infections that require antibiotic treatment.
  11. Measurable disease according to mRECIST criteria.
  12. Life expectancy over 6 months.

Exclusion Criteria:

  1. ECOG ≥ 1
  2. Child-Pugh ≥B8.
  3. Presence of ascitis or encephalopathy
  4. Extrahepatic tumoral disease.
  5. Tumoral vascular invasion
  6. Serum bilirubin>3 mg/dl.
  7. Cr Clearance ≤ 60 ml/min

  8. If any of the following is contraindicated:

    1. Administration of doxorubicin
    2. Iodated contrasts
    3. CT or MRI procedures
    4. Transarterial embolization procedures
    5. White blood cells (WBC) < 2000 /mm3
    6. Neutrophil count < 1500 /mm3
    7. Ejection fraction < 50 %
    8. Platelet count < 5 x 104/mm3, international normalized ratio (INR) > 2,0)
    9. Transaminases (AST and/or ALT) > 5x upper limit of normal or >250 u/l
    10. Known hepatofugal portal vein flow
    11. A-V intrahepatic macroscopic fistula
  9. Pregnant or breast feeding women.
  10. Tumor burden involving more than 50% of the liver.
  11. Active bacterial or fungal infection.
  12. Other concomitant tumors.
  13. Any other condition that according to investigator criteria, contraindicates DEB-TACE.
  14. Patients not willing to participate and/or give their written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with non resectable HCC
DEB-TACE with doxorubicin eluting 100 µ microspheres
Device: DEB-TACE
Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 30 days
Major and minor complications, procedure related mortality and post-embolisation syndrome after DEB-TACE of non-resectable HCC, using 100-µm doxorubicin-loaded microspheres
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2 years
Overall survival
2 years
Tumor Response
Time Frame: 6 months, 1 year, 2 year
Devascularization pattern in the treated tumor, assessed with the modified RECIST (mRECIST), in the contrast enhanced liver CT or MR obtained during FU.
6 months, 1 year, 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

  • Principal Investigator: Jose Urbano, MD, PhD,EBIR, HRyC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJD-TAN-14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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